Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217049
Company: ZYDUS PHARMS USA INC

Products on ANDA 217049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	5MG;2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	10MG;5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	12.5MG;2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	25MG;5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.